Altaire Recalls OCuSOFT Eye Drops Due to Sterility Concerns
Altaire Pharmaceuticals is recalling OCuSOFT Tears Again Sterile Lubricant Eye Drops because the company cannot guarantee the product's sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant injury or property damage risks, specifically regarding the lack of sterility assurance in a sterile product.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling OCuSOFT Tears Again Sterile Lubricant Eye Drops, 30mL bottles, NDC 54799-904-30. The recall is being conducted because the company lacks assurance of the product's sterility.
The recall involves 29,326 units distributed nationwide in the United States. Affected lots include those with codes 17208 (expiration 7/21), 17209 (expiration 7/21), and 19001 (expiration 1/23).
Consumers should stop using the product and contact Altaire Pharmaceuticals for further instructions or a refund.
The recalled product
- Product
- OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manufactured for OCuSOFT Inc., Rosenberg, TX 77471 USA, NDC 54799-904-30
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 29,326
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 17208 7/21 17209 7/21 19001 1/23
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 134 recalled by Altaire Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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